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The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients

Primary Purpose

Delirium

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fentanyl
Remifentanil
Normal saline
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signing a consent form
  • postoperative patient
  • Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours
  • Requirement for sedation
  • Age more than 18 and less than 85 years old

Exclusion Criteria:

  • Unstable blood circulation
  • Heart rate less than 50 beats per minute
  • II ° ～ III ° atrioventricular conduct block
  • Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate;
  • Receipt of antipsychotics 、hypnotic drugs before surgery ;
  • Alcohol abuse;
  • Liver failure class Child-Pugh C;
  • Acute Respiratory Distress Syndrome;
  • Acute or chronic renal failure;
  • Other severe diseases ,septic shock;
  • Receipt of neuromuscular blocking drug;
  • Pregnancy and nursing woman;
  • Allergy to investigational drug or other contraindication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Remifentanil，midazolam

    Fentanyl，midazolam

    Normal saline

    Arm Description

    Remifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation

    Fentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation

    Normal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation

    Outcomes

    Primary Outcome Measures

    The incidence and duration of delirium in patients with different regimens

    Secondary Outcome Measures

    Mortality
    Ventilator-free days
    Mean days of mechanical ventilation
    Length of ICU stay
    Index of anesthesia depth monitoring
    Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume
    Infusion velocity and total dose of sedative drugs in different groups
    Plasma melatonin level
    Total rescue dose of midazolam
    Variations of HR、RR、BP、SpO2

    Full Information

    First Posted
    February 28, 2014
    Last Updated
    July 15, 2014
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02078583
    Brief Title
    The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Remifentanil，midazolam
    Arm Type
    Experimental
    Arm Description
    Remifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation
    Arm Title
    Fentanyl，midazolam
    Arm Type
    Experimental
    Arm Description
    Fentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02~0.1mg/kg/h continuous intravenous pump for 7days or extubation
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Primary Outcome Measure Information:
    Title
    The incidence and duration of delirium in patients with different regimens
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    28 days
    Title
    Ventilator-free days
    Time Frame
    an expected average of 7 days
    Title
    Mean days of mechanical ventilation
    Time Frame
    an expected average of 7 days
    Title
    Length of ICU stay
    Time Frame
    an expected average of 7 days
    Title
    Index of anesthesia depth monitoring
    Description
    Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume
    Time Frame
    From admission to ICU to weaning,about 7 days
    Title
    Infusion velocity and total dose of sedative drugs in different groups
    Time Frame
    From admission to ICU to extubation or drug withdrawal,about 7 days
    Title
    Plasma melatonin level
    Time Frame
    Every 6 hours during the next ICU day
    Title
    Total rescue dose of midazolam
    Time Frame
    Seven days after giving midazolam to patient
    Title
    Variations of HR、RR、BP、SpO2
    Time Frame
    an expected average of 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signing a consent form postoperative patient Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours Requirement for sedation Age more than 18 and less than 85 years old Exclusion Criteria: Unstable blood circulation Heart rate less than 50 beats per minute II ° ～ III ° atrioventricular conduct block Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate; Receipt of antipsychotics 、hypnotic drugs before surgery ; Alcohol abuse; Liver failure class Child-Pugh C; Acute Respiratory Distress Syndrome; Acute or chronic renal failure; Other severe diseases ,septic shock; Receipt of neuromuscular blocking drug; Pregnancy and nursing woman; Allergy to investigational drug or other contraindication.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan Liu, Resident physician
    Phone
    +8613811365572
    Email
    fancyjuice@126.com

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients

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